510(k) · Cleared
ClearedHumerus & Ulna System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical Private Limited · HRS Plate, Fixation, Bone
Cleared on Nov 4, 2022 as substantially equivalent to K082625 (Synthes (Usa), 2008) and 1 other predicate after a 406-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- Nov 4, 2022
- Review
- 406 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981372 (1998). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- This deviceK213108 Humerus & Ulna SystemAuxein Medical Private Limited · 2022
- Descendant · cites it directly · 0 of its ownK240181 Clavicle and Scapula SystemAuxein Medical Pvt., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| 0 (this device) | K213108 | Humerus & Ulna System | Auxein Medical Private Limited | 2022 | — |
| +1 | K240181 | Clavicle and Scapula System | Auxein Medical Pvt., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082625 | Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus PlatesSummary page 7…claring substantial equivalence: The following is the range of variants covered with their corresponding predicate devices. Primary Predicate: 510K Number K082625 Applicant Synthes, USA Common Name Bone Fixation Plates Device Name 3.5mm LCP Periart… | 2008 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 7…USA Common Name Bone Fixation Plates Device Name 3.5mm LCP Periarticular Proximal Humerus Plates Other Predicate: 510K Number K082807 Applicant Synthes, USA Common Name 3.5 /4.5 mm LCP System Device Name Synthes 3.5mm L… | 2008 |
| † | K033995 | 3.5 MM LCP Distal Humerus System | 2004 |
| † | K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN… | 2015 |
| † | K082072 | Synthes (Usa) 3.5MM LCP Hook Plate | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240181 | Clavicle and Scapula System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K240181 (Auxein Medical Pvt., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K082625.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
Specific Indications: 1. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate is intended for treating of Intraarticular Fracture of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus. 2. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support is intended…
Read the full statement (577 words)
Specific Indications:
1. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate
2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate is intended for treating of Intraarticular Fracture of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
2. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support
2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support is intended for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
3. 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate
2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate are indicated for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
4. 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate
3.5mm Wise-Lock Extra-Articular Distal Humerus Plate are indicated for fractures of the distal humerus.
5. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Short
PHEELOS Short Indications
• Dislocated two-, three-, and four-fragment fractures of the proximal humerus
• Pseudarthroses in the proximal humerus
• Osteotomies in the proximal humerus
6. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Long
• As for PHEELOS Short, but for fractures extending to the shaft or without medial support.
7. 3.5mm Wise-Lock Proximal Humerus Plate
The 3.5mm Wise-Lock Proximal Humerus Plate is intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus.3
8. 3.5mm Wise-Lock Periarticular Proximal Humerus Plate
3.5mm Wise-Lock Periarticular Proximal Humerus Plate are indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus.
9. 3.5mm Wise-Lock Olecranon Plate
3.5mm Wise-Lock Olecranon Plate is indicated for fixation of fractures, osteotomies and non-unions of the olecranon.
10. 3.5mm Wise-Lock Hook Plate
3.5mm Wise-Lock Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula.
11. 2.7mm Wise-Lock Screw, Self-Tapping (Hex Head)
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
12. 3.5mm Wise-Lock Screw, Self-Tapping (Hex Head)
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
13. 3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head)
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
14. 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head)
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
15. 3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head)
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
16. 3.5mm Cortical Screw, Self-Tapping, (Hex Head)
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
17. 4.0mm Cancellous Screw, Short Thread
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
18. 4.0mm Cancellous Screw, Full Thread
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
19. 2.7mm Cortical Screw, Self-Tapping, (Hex Head)
This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213108: Humerus & Ulna System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213108
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026